Tetanus Clinical Trial
Official title:
Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine as Fifth Dose Booster in Children 4 to 6 Years of Age
Verified date | January 2014 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Currently, there is no 5-component acellular pertussis vaccine licensed for the 5th dose in
US children aged 4 to 6 years.This study is aimed at providing evidence of sero-protection,
booster response and safety of this formulation as a 5th dose.
Primary Objective:
- To compare the immune responses of Tetanus toxoid, reduced diphtheria toxoid, and
acellular pertussis (Tdap) Vaccine to Diphtheria, tetanus and acellular pertussis (DTaP)
vaccine (all antigens) when each is administered as a 5th dose and given concurrently, to
children aged 4 to 6 years.
Secondary/Observational Objectives:
- To compare the immune responses for pertussis antigens of Tdap Vaccine to DTaP vaccine
(for pertussis antigens) when each is administered as a 5th dose and given
concurrently, to children aged 4 to 6 years.
- To present the long-term immunogenicity at 1-, 3-, and 5-years post-vaccination after
each long-term follow-up.
- To describe the safety profile following vaccine administration.
Status | Completed |
Enrollment | 1045 |
Est. completion date | December 2009 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 4 Years to 6 Years |
Eligibility |
Inclusion Criteria : - Healthy, as determined by medical history and physical examination. - Aged 4 to 6 (< 7) years at the time of study vaccination on Day 0. - Signed and dated informed consent form that has been approved by the Institutional Review Board (IRB) by the parent or legally authorized representative. - Signed and dated informed assent form from the subject if required by the IRB. - Able to attend scheduled visits at Visit 1 and Visit 2 and able to comply with all trial procedures. Subjects will be invited to participate in the long-term immunogenicity follow-up study but a commitment to participate in the long-term is not required as an inclusion criterion. - Documented vaccination history of 4 previous doses of DAPTACEL according to the recommended national immunization schedule for Diphtheria, tetanus and acellular pertussis (DTaP). Exclusion Criteria : - Participation in another clinical trial in the 4 weeks preceding the trial vaccination. - Planned participation in another clinical trial during the original trial period. - Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy. - Systemic hypersensitivity to any of the vaccine components or history of life-threatening reaction to the trial vaccine or a vaccine containing the same substances. - Chronic illness at a stage that could interfere with trial conduct or completion. - Blood or blood-derived products received in the past 3 months. - Receipt of any other vaccine within 30 days prior to study vaccination, or planning to receive another vaccine within 30 days before the Visit 2 blood draw (with the exception of the annual influenza vaccine). - History of diphtheria, tetanus or pertussis infection (confirmed either serologically or microbiologically). - Thrombocytopenia or bleeding disorder contraindicating intra muscular vaccination. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sanofi Pasteur, a Sanofi Company |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Solicited Injection Site Reactions: Pain, erythema/redness, swelling, increased left limb circumference, and increased right limb circumference. Solicited Systemic Reactions: Fever (temperature), headache, malaise, and myalgia. | Days 0 to 7 post-vaccination | No |
Primary | Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at = 0.1 IU/mL Level | Seroprotection rate at level = 0.1 IU/mL was defined as antibody concentrations = 0.1 IU/mL. Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA). |
Pre-dose and 30 days post-vaccination | No |
Primary | Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level = 1.0 IU/mL | Serothreshold rate at level = 1.0 IU/mL was defined as antibody concentrations = 1.0 IU/mL. Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA). |
Pre-dose and 30 days post-vaccination | No |
Primary | Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis | Booster response was defined as post titer = 0.4 IU/mL and pre-titer < 0.1 IU/mL, or Post/Pre titer = 4 increase and pre titer = 0.1 IU/mL but < 2 IU/mL, or Post/Pre titer = 2 increase and pre-titer = 2 IU/mL Post-vaccination titers for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA). |
30 Days post-vaccination | No |
Primary | Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus | Booster response was defined as post titer = 0.4 IU/mL and pre titer < 0.1 IU/mL, or Post/Pre titer = 4 increase and pre-titer = 0.1 IU/mL but < 2 IU/mL, or Post/Pre titer = 2 increase and pre-titer = 2 IU/mL. Post-vaccination titers for Diphtheria was determined by neutralization assay; tetanus titers was determined by an enzyme-linked immunosorbent assay (ELISA). |
30 Days post-vaccination | No |
Primary | Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis | Pre- and post-vaccination GMTs and their 95% confidence intervals for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA). | Pre-dose and 30 Days Post-vaccination | No |
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